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Functional electrical stimulation cycling, goal-directed training, and adapted cycling for children with cerebral palsy: a randomized controlled trial [with consumer summary]
Armstrong EL, Boyd RN, Horan SA, Kentish MJ, Ware RS, Carty CP
Developmental Medicine and Child Neurology 2020 Dec;62(12):1406-1413
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIM: To test the efficacy of functional electrical stimulation (FES) cycling, goal-directed training, and adapted cycling, compared with usual care, to improve function in children with cerebral palsy (CP). METHOD: The intervention was delivered between 2017 and 2019 and included three sessions per week for 8 weeks (2x1 h sessions at a children's hospital, and 1 h home programme/week). Hospital sessions included 30 minutes of FES cycling and 30 minutes of goal-directed training. Home programmes included goal-directed training and adapted cycling. The comparison group continued usual care. Primary outcomes were gross motor function assessed by the Gross Motor Function Measure (GMFM) and goal performance/satisfaction assessed using the Canadian Occupational Performance Measure (COPM). Secondary outcomes were sit-to-stand and activity capacity, participation in home, school, and community activities, and power output. Linear regression was used to determine the between-group mean difference immediately post-training completion after adjusting for baseline scores. RESULTS: This randomized controlled trial included 21 participants (mean age 10 y 3 mo, standard deviation (SD) 3 y; Gross Motor Function Classification System level II = 7, III = 6, IV = 8) who were randomized to the intervention (n = 11) or usual care group (n = 10). Between-group differences at T2 favoured the intervention group for GMFM-88 (mean difference 7.4; 95% confidence interval (CI) 2.3 to 12.6; p = 0.007), GMFM-66 (mean difference 5.9; 95% CI 3.1 to 8.8; p < 0.001), COPM performance (mean difference 4.4; 95% CI 3.9 to 5.3; p < 0.001) and satisfaction (mean difference 5.2; 95% CI 4.0 to 6.4; p < 0.001). INTERPRETATION: Children with CP achieved meaningful functional improvements after FES cycling, goal-directed training, and adapted cycling training. Cycling programmes for children with CP should be individualized and goal directed.

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